How will you navigate the new TMF regulatory landscape?
Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Practical Steps to Selecting and Implementing an eTMFMontrium
There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so.
However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting result in unsuccessful or sub-optimal eTMF implementations.
This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
The Webinar will cover the following topics:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
Empowering Active TMF Management With an eTMF SystemMontrium
Active TMF Management is critical when conducting a trial. Managing your trial documentation on an on-going basis will allow organizations to have greater oversight on the completeness, empower team members to submit content in timely manner, and ultimately be continuously inspection ready all the while monitoring the quality of your documents.
In our upcoming webinar, we will be exploring how to use an eTMF system to its full capacity by empowering active TMF Management. We'll start by understanding the measurable benefits gained by managing an active TMF and the disadvantages of having a passive TMF repository.
We will also dive deeper into some of the features Montrium has developed as part of our eTMF which empowers clinical teams and gives organization's the tool to have a successful study.
During this webinar, you'll learn:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Practical Steps to Selecting and Implementing an eTMFMontrium
There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so.
However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting result in unsuccessful or sub-optimal eTMF implementations.
This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.
In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We'll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.
The Webinar will cover the following topics:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
Empowering Active TMF Management With an eTMF SystemMontrium
Active TMF Management is critical when conducting a trial. Managing your trial documentation on an on-going basis will allow organizations to have greater oversight on the completeness, empower team members to submit content in timely manner, and ultimately be continuously inspection ready all the while monitoring the quality of your documents.
In our upcoming webinar, we will be exploring how to use an eTMF system to its full capacity by empowering active TMF Management. We'll start by understanding the measurable benefits gained by managing an active TMF and the disadvantages of having a passive TMF repository.
We will also dive deeper into some of the features Montrium has developed as part of our eTMF which empowers clinical teams and gives organization's the tool to have a successful study.
During this webinar, you'll learn:
• What challenges are present when using an eTMF solely as a repository?
• What it means to have active TMF Management with an eTMF System
• How to empower clinical teams to collaborate and treat TMF as a living document
• What tools an eTMF provides to allow for active management
• What benefits active TMF management provides
• Introduction to Montrium's eTMF
• Plus much more...
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
Transforming eTMF Management: Moving to a Data-Driven ApproachMontrium
We are moving towards a digital age of automation in clinical trials where electronic management of content and data to document activities and decisions is the industry-wide norm.
This means that the concept of TMF is also evolving and is no longer just a document repository, but rather a collection of systems holding content and data. As a result, there is a strong business case from moving away from just archiving documents to actively managing TMF content and information using techniques and practices borrowed from clinical data management.
In this webinar, we will look at how you can use queries, data review and process-based approaches to ensure that your TMF tells an accurate and complete story of what occurred in your study. We will also discuss the greater scope of TMF relevant information and systems and how you can best integrate these sources into a more holistic environment to greatly facilitate inspections and clinical trial oversight.
Best practices for preparing for and surviving inspectionsMontrium
Inspections are the apex of the clinical trial. It is something that we prepare, plan for and ultimately dread for the entire duration of the study. Being inspection ready can take a significant burden off your clinical team, maximize time and get your product to market faster.
In our upcoming webinar, we will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and some key strategies to ensure your team has a successful inspection.
We will also dive deeper into some of the tools Montrium has developed that give your clinical teams an edge when it comes to surviving inspections, and providing your team greater oversight into eTMF completeness.
The Webinar will cover the following topics:
• Why is preparing for inspections important?
• What are some of the challenges organizations face when it comes to inspections?
• Why is it difficult to be inspection ready at all times?
• Best practices when preparing for an upcoming inspection
• How to survive the inspector
• Introduction to Montrium's eTMF
• Plus much more...
Advance Information Management Through eTMF and CTMS ConvergenceWingspan Technology
With the increasing need for oversight of studies taking place across the globe, effective TMF management through an eTMF is just the tip of the iceberg for enhancing your organizations’ collaboration strategies. By utilizing an eTMF in conjunction with a CTMS, the opportunity to improve management of information is afforded.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Best practices for preparing for and surviving inspectionsMadison Ramsay
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Presentation from the 2016 MAGI West conference on how to prepare your organization for inspection readiness by focusing on processes, governance, and tools.
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Good Clinical Practice (GCP) and Trial Master File.pptxManish Gautam
The TMF should be held at the coordinating site (usually the Chief Investigator’s office or Coordinating Centre) and for multi-site trials, copies of relevant documents should be kept at each participating site in an Investigator Site File (ISF). Most sponsors will provide guidance on the content and set up of the TMF/ISF based on their local policies/procedures.
Automation of document management paul fenton webinarMontrium
In the life sciences, most of the documents we create end up as records. Now, as we move towards a paperless era in today’s GxP environment and leverage digital content management technology, we are also starting to change the way that we author, collaborate, manage, exchange, and archive our documents.
The very nature of document management is transforming as more and more data becomes part of the document management landscape. In this webinar, we explore how technology is transforming our GxP records management environments and what the future may hold for automating processes
The way we manage the TMF is constantly evolving. Regulations are often catalysts to change in the eTMF space and staying on top of industry trends is vital in making sure you are working in the best possible way.
In our presentation, we will be exploring 5 of the hottest trends in the future of eTMF which include interoperability, traceability and data integrity, challenges of inspection when data is spread in multiple systems, and how the industry would be affected by the potential ratification of the TMF Reference Model by ICH.
We will also dive deeper into the inner workings of these trends and how we can begin to solve some of these issues which are spreading in the industry.
The presentation covers the following topics:
- Where the industry is today regarding eTMF
- What regulatory bodies are initiating change in the clinical space
- How the ICH is a catalyst to change in the TMF reference model
- Traceability and data integrity in today's model
- Challenges of inspection with disparate systems
- Interoperability and the future of eTMF
- Plus much more...
Follow along via our webinar:
https://info.montrium.com/the-future-of-etmf-actionable-industry-trends-and-insights
Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMontrium
The Covid-19 pandemic has forced the pharmaceutical and medical device industries to explore methods beyond the traditional on-site monitoring and auditing of clinical trial sites. It has enabled companies to leverage both existing technologies and quickly adopt new methodologies to ensure data integrity and patient safety.
With these changes, companies are able to identify opportunities for both increased quality and efficiencies in their clinical trials.
In this webinar, we will discuss:
Opportunities and the challenges of the “new normal” in the management and oversight of clinical trials
Insights into how we think technology will evolve in the future to better support new risk based approaches to oversight
AI's growing role in clinical trial oversight
Best Practices for Implementing Robust Governance Processes in Office 365Montrium
With Office 365 cloud services, it’s up to customers to manage GxP data governance, authorize access, and configure settings to ensure data integrity. However, given Office 365’s highly customizable nature, many teams face frustrations when establishing governance provisions.
To combat the challenges that come with a continuously evolving system, we will share how you can establish/adapt governance processes to accommodate for smaller, frequent changes. During the webinar, you will learn how Office 365 customers' data benefits from having multiple layers of granular control within a robust governance model to support the management of GxP content.
The webinar covers the following topics:
Overview of IT Governance
Risk-based approach tied to Governance: identifying and mitigating risks in the cloud
Methodology for a good Office 365 Governance strategy
Office 365 Governance with Technical Controls
Compliance Monitoring Overview
More Related Content
Similar to Integrating and appling tmf regulation into your buisness process
Transforming eTMF Management: Moving to a Data-Driven ApproachMontrium
We are moving towards a digital age of automation in clinical trials where electronic management of content and data to document activities and decisions is the industry-wide norm.
This means that the concept of TMF is also evolving and is no longer just a document repository, but rather a collection of systems holding content and data. As a result, there is a strong business case from moving away from just archiving documents to actively managing TMF content and information using techniques and practices borrowed from clinical data management.
In this webinar, we will look at how you can use queries, data review and process-based approaches to ensure that your TMF tells an accurate and complete story of what occurred in your study. We will also discuss the greater scope of TMF relevant information and systems and how you can best integrate these sources into a more holistic environment to greatly facilitate inspections and clinical trial oversight.
Best practices for preparing for and surviving inspectionsMontrium
Inspections are the apex of the clinical trial. It is something that we prepare, plan for and ultimately dread for the entire duration of the study. Being inspection ready can take a significant burden off your clinical team, maximize time and get your product to market faster.
In our upcoming webinar, we will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and some key strategies to ensure your team has a successful inspection.
We will also dive deeper into some of the tools Montrium has developed that give your clinical teams an edge when it comes to surviving inspections, and providing your team greater oversight into eTMF completeness.
The Webinar will cover the following topics:
• Why is preparing for inspections important?
• What are some of the challenges organizations face when it comes to inspections?
• Why is it difficult to be inspection ready at all times?
• Best practices when preparing for an upcoming inspection
• How to survive the inspector
• Introduction to Montrium's eTMF
• Plus much more...
Advance Information Management Through eTMF and CTMS ConvergenceWingspan Technology
With the increasing need for oversight of studies taking place across the globe, effective TMF management through an eTMF is just the tip of the iceberg for enhancing your organizations’ collaboration strategies. By utilizing an eTMF in conjunction with a CTMS, the opportunity to improve management of information is afforded.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Best practices for preparing for and surviving inspectionsMadison Ramsay
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Best practices for preparing for and surviving inspectionsMontrium
We will be exploring the best practices for preparing and surviving TMF inspections. We'll start by diving into why inspection readiness should be continuous, and share some key strategies to ensure your team has a successful inspection.
Presentation from the 2016 MAGI West conference on how to prepare your organization for inspection readiness by focusing on processes, governance, and tools.
A Trial Master File (TMF) is set up at the beginning of the trial. It is a collection of all essential documents pertaining to the trial, which in turn will allow for effective monitoring and supervision (audit). In order to demonstrate compliance with the applicable regulations, Good Clinical Practice (GCP) guidelines and the protocol – a well organised TMF is essential.
According to the GCP guidelines, it is the responsibility of the sponsor to ensure that the TMF includes all relevant essential documents, and is stored in a secure location, with restricted access. Generally, the TMF is maintained at the sponsor’s office, co-ordinating site or by the Contract Research Organisation (CRO), if contracted. In addition to the TMF, copies of all relevant documents must be kept at each participating site, in an Investigator Site File (ISF). The ISF will also include all site-specific essential documents. For example, site preparedness log or site visit logs, etc.
A member of the research or trial team should be delegated with the task of updating, maintaining and reviewing the TMF and ISF, periodically throughout the course of the clinical trial as per the defined SOPs. Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
Training documentation for the trial team
Details of the laboratories, if applicable.
Contracts, agreements, budgets, etc.
Monitoring visit reports (for each site visit onsite or central)
Documents related to the safety reporting
Ethics Committees documents (composition of the EC, approvals, notifications, reports, etc.)
Site-specific documents (list of site staff and their curriculum vitae, investigator’s undertaking, site preparedness documents, training of site staff, etc.)
Audit related documents, if available (if an audit was conducted).
Significant communications
Others
The GCP guidelines provide comprehensive guidance regarding the documents to be included in a Trial Master File categorised according to the lifecycle of the trial. This information can also be accessed here.
It shall be the responsibility of the sponsor to make arrangements for the safe and secure custody of all study-related documents and material for a period of three years after the completion of the study or submission of the data to the regulatory authority(ies) whichever is later.
Good Clinical Practice (GCP) and Trial Master File.pptxManish Gautam
The TMF should be held at the coordinating site (usually the Chief Investigator’s office or Coordinating Centre) and for multi-site trials, copies of relevant documents should be kept at each participating site in an Investigator Site File (ISF). Most sponsors will provide guidance on the content and set up of the TMF/ISF based on their local policies/procedures.
Automation of document management paul fenton webinarMontrium
In the life sciences, most of the documents we create end up as records. Now, as we move towards a paperless era in today’s GxP environment and leverage digital content management technology, we are also starting to change the way that we author, collaborate, manage, exchange, and archive our documents.
The very nature of document management is transforming as more and more data becomes part of the document management landscape. In this webinar, we explore how technology is transforming our GxP records management environments and what the future may hold for automating processes
The way we manage the TMF is constantly evolving. Regulations are often catalysts to change in the eTMF space and staying on top of industry trends is vital in making sure you are working in the best possible way.
In our presentation, we will be exploring 5 of the hottest trends in the future of eTMF which include interoperability, traceability and data integrity, challenges of inspection when data is spread in multiple systems, and how the industry would be affected by the potential ratification of the TMF Reference Model by ICH.
We will also dive deeper into the inner workings of these trends and how we can begin to solve some of these issues which are spreading in the industry.
The presentation covers the following topics:
- Where the industry is today regarding eTMF
- What regulatory bodies are initiating change in the clinical space
- How the ICH is a catalyst to change in the TMF reference model
- Traceability and data integrity in today's model
- Challenges of inspection with disparate systems
- Interoperability and the future of eTMF
- Plus much more...
Follow along via our webinar:
https://info.montrium.com/the-future-of-etmf-actionable-industry-trends-and-insights
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Monitoring Beyond COVID-19: Setting Yourself Up for the New-NormalMontrium
The Covid-19 pandemic has forced the pharmaceutical and medical device industries to explore methods beyond the traditional on-site monitoring and auditing of clinical trial sites. It has enabled companies to leverage both existing technologies and quickly adopt new methodologies to ensure data integrity and patient safety.
With these changes, companies are able to identify opportunities for both increased quality and efficiencies in their clinical trials.
In this webinar, we will discuss:
Opportunities and the challenges of the “new normal” in the management and oversight of clinical trials
Insights into how we think technology will evolve in the future to better support new risk based approaches to oversight
AI's growing role in clinical trial oversight
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With Office 365 cloud services, it’s up to customers to manage GxP data governance, authorize access, and configure settings to ensure data integrity. However, given Office 365’s highly customizable nature, many teams face frustrations when establishing governance provisions.
To combat the challenges that come with a continuously evolving system, we will share how you can establish/adapt governance processes to accommodate for smaller, frequent changes. During the webinar, you will learn how Office 365 customers' data benefits from having multiple layers of granular control within a robust governance model to support the management of GxP content.
The webinar covers the following topics:
Overview of IT Governance
Risk-based approach tied to Governance: identifying and mitigating risks in the cloud
Methodology for a good Office 365 Governance strategy
Office 365 Governance with Technical Controls
Compliance Monitoring Overview
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In this webinar, we will discuss strategies for calculating accurate completeness as well as review other key metrics that enable you to assess your TMF health and inspection readiness.
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In this webinar, your host Chrysa will discuss how Office 365 customers' data benefits from having multiple layers of granular control within a robust governance model to support the management of GxP content.
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Ultimately, the responsibility to validate GxP applications is on customers and partners of Microsoft - so we take a look at how to build out a validation plan and control protocols for successful integration with your existing system.
We uncover how Office 365 satisfies specifications of FDA’s 21 CFR Part 11 and EU Annex 11 from both a procedural and technical approach to satisfy regulatory conditions, and how the balance of shared responsibilities between Microsoft and its life sciences customers can satisfy regulatory requirements.
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The presentation covers the following topics:
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In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
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-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Why Are Life Science Companies Moving to Office 365?Montrium
The webinar will cover the following topics:
-Moving away from costly and inefficient legacy systems
-Key GxP features and capabilities available in the cloud
-Case studies of Office 365 across the life sciences landscape
-What comes with a continuous Office 365 Validation Subscription?
-Montrium methodology, tools, and documentation available to you
Automating the Regulatory Submission Process - Reducing Time and Increasing Q...Montrium
In this presentation, we will be exploring how technology can be leveraged to improve submission readiness and the quality of your electronic submissions. Discover why planning submissions is important, and examine some of the key components of a successful submission readiness plan.
Follow along via webinar format:
https://info.montrium.com/webinar-automating-the-regulatory-submission-process
In this presentation, we explore the ways you can get internal buy-in and how to build out your business case. We will start by breaking down an eTMF business case and going through the sections you’ll need to include to have a successful meeting internally.
Follow along via our webinar:
https://info.montrium.com/webinar-how-to-build-the-business-case-for-an-etmf-system
Whether it’s meeting the next big client, forming your next business partnership, learning new skills, getting advice from peers, or keeping up with industry information, the return on investment of attending the right events can be substantial.
As a technology vendor that regularly exhibits, speaks and advises clinical conferences all over the world, we’ve seen and attended our fair share of fantastic, and not so fantastic industry conferences. Let’s be honest, there are hundreds of conferences scattered on every continent, but which one is going to give you the best return for your time and money? We’ve laid out our list of top conferences to attend in 2019 that will make you want to start packing today.
The ability to meet standards and regulatory approval is nowhere more important than in the pharmaceutical industry. All companies have responsibilities when it comes to submitting information to authorities in both a precise and proper manner as, otherwise, their latest developments and innovations could be held back by dreaded red tape.
Document Management in the Life Sciences - New Horizons for Small-Medium Ente...Montrium
Efficient management of documentation is key to the successful development of new molecules. It is also often one of the most challenging aspects of managing a clinical program. There are efficiencies to be had through the use of an electronic system compared to paper, however, these systems can be time consuming and expensive to put in place. This webinar will focus on the challenges and opportunities that small to medium enterprises face when trying to improve their document management processes within the context of clinical trials.
Topics will include:
• Where we have come from and where we are today
• Drivers to adopt electronic document and records management
• Changing regulatory expectations
• What are my options – Paper, On-Premise, Cloud
• Benefits of a structured approach to EDM
• Document Management Challenges faced by SMEs
• Montrium’s approach to delivering Document Management for the Life Sciences in the cloud
• Future Trends in Records Management
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
3. 3
Agenda
LIVE WEBINAR
1. Review key aspects of regulations governing TMF
2. Discuss the big issues relating to the
implementation of the regulations
3. Explore practical considerations for complying with
the regulations
5. 5
House
Keeping
L I V E W E B I N A R
• This webinar is being recorded and
will be made available after this
session
• Feel free to use the chatbox to
submit your questions at anytime
• Q&A will take place at the end of
the webinar
9. FDA CGMP
Guideline on GCP compliance in
relation to trial master file (paper
and/or electronic) for content,
management, archiving, audit and
inspection of clinical trials (March
2017)
Integrated addendum to
ICH E6(R1): Guideline for
Good Clinical Practice
E6(R2) (November 2016)
MHRA GxP Data Integrity
Definitions and Guidance for
Industry Draft version (July
2016)
FDA Data Integrity and
Compliance with CGMP
(April 2016)
FDA Use of Electronic Records and
Electronic Signatures in Clinical
Investigations Under 21 CFR Part 11
Questions & Answers’
(June 2017)
21 CFR PART 11
MHRA GxP Data
Integrity
Definitions
ICH
E6 (R2)
EMA
15975/2016
11. Certified
Copies and
Destruction
of Paper
ICH
“A copy (irrespective of the type of media used) of the original record that has
been verified (i.e. by a dated signature or by generation through a validated
process) to have the same information, including data that describe the context,
content and structure, as the original.”
ICH
“[…] When a copy is used to replace an original document (e.g., source
documents, CRF), the copy should fulfill the requirements for certified copies.”
FDA
“The copy of the original record should be verified as having all of the same
attributes and information as the original record and certified as indicated by a
date signature.”
EMA
A certified copy is a paper or electronic copy of the original record that has been
verified (e.g. by a dated signature) or has been generated through a validated
process to produce a copy having the exact content and meaning of the
original.”
12. Certified Copies & Destruction of Paper
Big Issues Practical Considerations
• FDA guidance is currently not in line with ICH E6
R2 or EMA
• How practical is it to sign certified copies
(electronically or handwritten)?
• Do we destroy paper or not?
• Define what is a record and what you understand
to be a certified copy
• Develop a process for validation of certified
copies, including ongoing QC, should be detailed
in SOPs to ensure consistency
• Remember that a certified copy is only required if
the copy is permanently replacing the original or
if the eTMF is being presented as the official TMF,
for example, during an inspection
• Only destroy paper if you are confident that your
validated process works
• Remember to initiate documents electronically if
you can
13. Have you generated certified copies and
destroyed paper records in your organization?
1) Yes, after putting in place a validated
process
2) Yes, after certifying copies with a signature
3) Yes, after putting in place a validated
process and certifying copies with a
signature
4) No, we still maintain paper records
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14. Audit
Trails
EMA
“audit trail […] to identify date/time/user details for creation, uploading, approval
and deletion of and changes to a document”
FDA
“audit trail is a process that captures details of information, such as additions,
deletions, or alterations, in an electronic record without obscuring the original
record. An audit trail facilitates the reconstruction of the course of such details
relating to the electronic record.”
FDA
"Electronic audit trails include those that track creation, modification, or deletion
of data (such as processing parameters and results) and those that track actions
at the record or system level (such as attempts to access the system or rename
or delete a file)."
MHRA
"There should be adequate traceability of any user defined parameters used
within data processing activities. Audit trails and retained records should allow
reconstruction of all data processing activities regardless of whether the output
of that processing is subsequently reported or otherwise used."
15. Audit Trails
Big Issues Practical Considerations
• When does an artifact become a record?
• What metadata or processing parameters need to
be audit trailed?
• What is an audit trail vs transaction log and where
does it apply?
• Data integrity guidance is still in draft
• Define what you consider to be a record (records
management process) and what needs an audit
trail (system requirements) based on your
interpretation of the regulations
• Transaction logs are useful – ask your vendors
what they offer and include this in your
specifications
• Lobby the regulators to come up with better
descriptions and requirements
16. TMF Scope
&
Signposts
ICH
"The sponsor and investigator/institution should maintain a record of the
location(s) of their respective essential documents including source documents.”
EMA
“The sponsor and the investigator should identify and make a record of the
location(s) of all the potential documentation that is considered to form the TMF,
even if several locations, departments, country organizations and systems are
involved, so that it is effectively organized.”
17. TMF Scope & Signposts
Big Issues Practical Considerations
• How do you present TMF information to an
inspector that is contained in multiple different
systems and locations?
• What is TMF relevant?
• When multiple systems are involved, what is the
authoritative source?
• In the TMF plan, specify what is TMF relevant,
authoritative source vs. shadow and where this
information is being held
• Label artifacts in eTMF as authoritative source or
shadow copies
• Identify TMF records using signposts within your
eTMF, if your system allows you to do it
• Define process for access to signposted content
being held in different locations
18. TMF
Exchange
EMA
“When different TMF systems are linked to facilitate the trial conduct, for
example the CRO eTMF system uploads documents into the sponsor eTMF
system, the process for transferring documents should be robust and should be
validated to prevent failure of transferring parts of the entire content of the
original TMF without loss i.e. there should be a demonstrable 1:1 mapping
between the content of the two systems.”
FDA
“During an inspection, FDA will focus on any source data that are transferred to
another data format or system to ensure that checks are in place and critical
data are not altered in value or meaning during the migration.”
19. TMF Exchange
Big Issues Practical Considerations
• How do you conduct exchange of TMF information
across different eTMF systems:
• At the end of a study?
• In the case of a merger and acquisition?
• In the case of interim TMF transfers?
• In the case of an inspection?
• Mapping metadata and migrating content is time
consuming and error prone
• Transferred content, if electronic, must be held in a
compliant manner
• TMF RM exchange mechanism standard will
hopefully solve this problem
• Find out from your vendor if they plan to support the
TMF RM exchange mechanism standard
20. Timeliness
EMA
“Article 57 states “the clinical trial master file shall at all times contain the
essential documents relating to that clinical trial.” The requirement “at all times”
means that the TMF should be updated, and completed in a timely manner.”
EMA
“[…] it is important, therefore, to keep the TMF up to date, with documents
placed in the TMF in a timely manner as this greatly assists the successful
management of a trial by the investigator and sponsor (or party to whom the
sponsor has delegated its duties).”
ICH
“Filing essential documents at the investigator/institution and sponsor sites in a
timely manner can greatly assist in the successful management of a trial by the
investigator, sponsor and monitor.”
21. Timeliness
Big Issues Practical Considerations
• Terminology used in the guidance is vague and
open to interpretation
• What is timeliness?
• What date determines timely completion?
• Consider a process to define when TMF artifacts
need to be in a TMF
• Establish methods for measuring timeliness and
standards around dates
• eTMF should have a mechanism for detecting
missing artifacts
• Most documents can be tied to a milestone
• e.g. Site Selected -> Site Initiated
• Compliance with protocol timelines, study
plans established at trial start
22. What do you consider to be timely filing of TMF
content (artifacts) in your organization?
1) Artifacts must be filed as soon as they are
produced
2) Artifacts must be filed within 30 days or less
of their production
3) Artifacts must be filed within 3 months of
their production
4) Artifacts must be filed before the end of the
study
5) We do not have a policy on timely filing of
artifacts
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23. Direct
Access
EMA
“With reference to Article 57 of the Regulation, direct access to the TMF is
expected.”
EMA
“Direct access includes all the systems that comprise the TMF as defined by the
sponsor […]”
EMA
The eTMF should allow review in an efficient manner, analogous to that possible
with paper TMFs.”
EMA
“Any training should be an option for the inspector to choose and is anticipated
to be very brief (taking no more than an hour).”
24. Direct Access
Big Issues Practical Considerations
• Systems are not well-adapted for
inspector use (especially with minimal
training)
• Many systems could hold TMF content
and providing direct access to all
systems becomes challenging
• How do you control access to
inspectable content only?
• Include a section in TMF plan for inspections
• Define which systems contain TMF content and
plan for access in the case of inspection
• Establish whether inspector will have direct access
(is there an interface for this provided by your
vendor?) or guided access (who will do it?) or will
you provide a verified listing?
• Include requirements in your eTMF for inspector view
• For other systems, evaluate whether that capability exists,
otherwise consider guided access
25. Have you experienced an inspection where direct
access was requested?
1) Yes
2) No
3) I don’t know
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26. Record
Retention
ICH
ICH E6: at least 2 years after marketing approval or at least 2 years since the
discontinuation of clinical development of the investigational product.
ICH
Regulation in ICH countries
• EMA (EU): At least 25 years after end of trial
• MHLW (Japan): Until the day marketing approval is obtained or 3 years
after date of premature termination or completion of the clinical trial,
whichever comes later
• FDA (US): 2 years after marketing approval or 2 years after shipment
and delivery of IP is discontinued
• Health Canada (Canada): 25 years after end of trial
• Swissmedic (Switzerland): at least 10 years after completion or
discontinuation of the trial (15 years for implantable devices)
27. Record
Retention
ICH
Ensure the integrity of the data including any data that describe the context,
content and structure of the data. This is particularly important when making
changes to the computerized systems, such as software upgrades or migration.“
EMA
"Media used to store the data may potentially deteriorate or become obsolete,
thus transfer to an alternative would need to be considered. The media should
be stored under appropriate conditions. Any transfer or migration needs to be
validated. The transfer of data to new media as technology advances would
need to be considered by the organisation."
28. Record Retention
Big Issues Practical Considerations
• How do you retain electronic records for 25 years?
(Remember those floppy disks)
• No real harmonization between RAs...
• Define the plan for archiving at the beginning of a
trial
• Define process for periodic verification of archived
electronic records
• Follow ISO standards
• ISO 19005, Document management –
Electronic document file format for long-term
preservation – Part 1, Use of PDF 1.4 (PDF/A-
1)
29. Cloud
Computing
FDA
Ensure adequate controls in place to ensure reliability and
confidentiality of the data.
Some key factors to consider:
• Validation documentation
• Ability to generate accurate and complete copies of records
• Availability and retention of records for FDA inspection for as long as records
are required by
• Archiving capabilities
• Access controls
• Secure, computer-generated, time-stamped audit trails of users’ actions and
changes to data
• Encryption of data at rest and in transit
• Electronic signature controls
• Performance record of the electronic service vendor and the electronic service
provided
• Ability to monitor the electronic service vendor’s compliance with electronic
service security and the data integrity controls
30. Cloud Computing
Big Issues Practical Considerations
• How do you ensure that whoever is holding your
eTMF content in the cloud allows you to meet the
regulatory requirements around electronic
records?
• Lack of guidance from the regulators with regards
to cloud computing
• Important to establish who is responsible for what
(vendor, subcontractors, third parties) (quality
agreements)
• Ask vendor how they meet 21 CFR part 11
requirements
• Ask industry colleagues how they’ve done it
• Perform due diligence – regularly
• Look for certifications like SOC and ISO
31. Site
Documents
/eISF
EMA
“The investigator TMF may be electronic with the system either provided
by the sponsor, a vendor or health care institution. A situation where all
the investigator site records are sent to the external sponsor for
uploading onto an eTMF system, which the investigator then accesses
via a portal, would potentially breach data privacy requirements and give
sole custody to the sponsor for source documents. Therefore, such a
construct is considered unacceptable. Remote access, i.e. access to
investigator documentation at the investigator site from a different
location by sponsor personnel, to personal data of trial subjects in the
investigator TMF, is unacceptable. Where a portal is used to provide
documents to the investigator, if this is not part of the investigator TMF
there needs to be a mechanism to ensure such documentation is filed in
the official investigator TMF. Also, there should be an audit trail to
demonstrate investigator access to documents in the portal at the
appropriate time.”
EMA
“In organizing the TMFs, it is essential to segregate some documents
that are generated or held by the sponsor only, from those that are
generated or held by the investigator only, and vice versa.”
32. Site Documents/eISF
Big Issues Practical Considerations
• Sponsor cannot hold certain site documents and
vice versa
• Do sites really want another system?
• How can you ensure that sites are properly
maintaining their ISF?
• Ask your vendor about the mechanism in place to
segregate site only vs. sponsor only documents
• Evaluate eISF systems that may exist to see if
they are a fit. Remember that the Sponsor cannot
hold the ISF for the site
33. Risk Based
TMF
ICH
“Evolutions in technology and risk management processes offer new
opportunities to increase efficiency and focus on relevant activities. […]
Advances in use of electronic data recording and reporting facilitate
implementation of other approaches.”
EMA
“The essential documents for the trial may be supplemented or may be reduced
where justified (in advance of the trial initiation), based on the importance and
relevance of the specific documents to the trial.”
EMA
“As part of the validation a formal process should be in place for regular QC
checks of digitised and indexed documents in the e-TMF. This would usually be
undertaken on a sampling basis, including escalation procedures where errors
occur beyond a pre-defined Acceptance Quality Limit (AQL). ”
34. Risk Based TMF
Big Issues Practical Considerations
• We don’t take a risk based approach today....
• How do you demonstrate and measure quality?
• Multiple vendors, multiple systems makes risk
management challenging
• Difficult to join the dots to fully understand the
sequence of events
• Define a plan for risk-based TMF review, consider:
• Study design and complexity
• Number of vendors
• Number of systems used containing TMF records
• Assigning risk scores to document types based on
process risk and other factors
• Ask your vendor if they have or plan to introduce
risk based functionality for QC and risk
identification
• Think about how you can better organize
information to better tell the story of what
happened and leverage this information to assess
risk
35. Sponsor
Oversight
ICH
“The sponsor should ensure oversight of any trial-related duties and functions
carried out on its behalf, including trial-related duties and functions that are
subcontracted to another part by the sponsor’s contracted CRO(s).”
EMA
“The sponsor may choose to outsource duties and functions of the sponsor to a CRO
The sponsor remains responsible for the trial and will need to maintain oversight, so
access to the sponsor TMF (e.g. remote access to an e-TMF) or at least to relevant
documents from it will be necessary in order to discharge their responsibilities
effectively.”
EMA
“FDA recognizes that sponsors and other regulated entities may choose to
outsource electronic services. […] When these electronic services are used to
process data for FDA-regulated clinical investigations, sponsors and other
regulated entities should consider whether there are adequate controls in place
to ensure the reliability and confidentiality of the data.”
36. Sponsor Oversight
Big Issues Practical Considerations
• What is oversight?
• How do you demonstrate and measure it to
provide evidence of oversight?
• Define process for sponsor TMF oversight in TMF
plan
• Define methods for oversight for example,
process for QC and QA of the TMF by the
sponsor and supporting documentation
• Define KPIs in service level agreements
• Avoid duplicate records available at sponsor and
vendor levels – increases risk for error and
inconsistency. Use signposts and defined process
for access instead.
37. Do you feel that the regulations that are in place
provide enough clarity on what is required in
relation to TMF and eTMF systems?
1) Yes, the regulations are clear
2) No, the regulations are not specific enough
and do not provide enough clarity
3) I don’t know
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A B O U T T H E C O M P A N Y
38. State of the Union
S E C T I O N # 2
38A B O U T T H E C O M P A N Y
Presented by Paul
39. • TMF is changing – moving away from being a document repository and
moving towards being an information management system
• TMF is a gold mine of information which if leveraged in the right way
can not only tell a better story of what happened in the study but also
provide more insight into study risks
• The regulators seems to be moving quickly and not everything is
100% clear yet
State of the Union
40. • The future of eTMF will be more data driven, connected and holistic
and will focus on presenting processed based views of study activities
• Easier exchange of eTMF information and artifacts is on the horizon
with the implementation of the TMF RM Exchange Mechanism
Standard
• Paper is starting to finally disappear and a new wave of more
intelligent eTMF solutions should be here soon!
State of the Union
41. 41
• Facilitate exchange of clinical trial
information to all stakeholders
• Accurately track the progress of
TMF completeness
• Quickly comply with regulatory
requirements, audits and
inspections
A Complete eTMF
Platform Engineered for
Growth Organizations
42. Are you interested in receiving more information
about eTMF Connect?
1) Yes, could be useful
2) No, not interested
42
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